Friday, January 11, 2008

Macy Foundation Bombshell: Industry-Funded CME Must End

The clock is ticking for industry-funded medical education. The latest body blow comes in the form of a report on medical education issued by the influential Josiah Macy, Jr. Foundation. Read it here. The report was the product of a conference attended by many of the brightest minds in medicine, including Catherine DeAngelis, editor-in-chief of JAMA, Harvey Fineberg, president of the Institute of Medicine, and David Leach, recent executive director of the Accreditation Council for Graduate Medical Education.

The Macy Foundation couldn't be clearer: commercial support of CME has got to go.

Here is the most powerful section of their report (you can find it on page 2 from the link above): "Participants warned that the health professions, especially medicine, threaten the ethical underpinnings of professionalism by participating in a multi-billion dollar CE enterprise so heavily financed by commercial interests. This arrangement, which evolved over the years, distorts continuing education. It places physicians and nurses who teach CE activities in the untenable position of being paid, directly or indirectly, by the manufacturers of health care products about which they teach.

At the same time, commercial support of CE places learners in an obligatory position because they are often given free meals and small gifts. Independent judgment of how best to care for patients is compromised. Bias, either by appearance or reality, has become woven into the very fabric of continuing education.

The professions, themselves, must right this wrong. In a free-market system, commercial entities, such as drug and device manufacturers, have a clear responsibility to shareholders to gain market advantage and generate a profit, while health professionals have a moral responsibility to provide safe, high quality care for their patients, based on valid scientific findings. The two responsibilities are fundamentally incompatible.

Even if bias could be avoided, the potential, and the perception, are ever-present. Companies with billions of dollars at stake cannot be expected to be neutral or objective when assessing the benefits, harms and cost-effectiveness of their products, for they are in the legitimate business of gaining market advantage and want clinicians to use and prescribe their products. Yet, an objective and neutral assessment of clinical management options is precisely what is needed in continuing education.

Participants emphasized that, regardless of the financial impact on for profit companies, patient care must be based on scientific evidence and commercial interests should not determine the topics or content of CE. Because of these underlying ethical issues, participants concluded that the commercial entities that manufacture and sell health care products should not provide financial support for the continuing education of health professionals (emphasis added)."

While I thoroughly agree with the Macy Foundation Chairman's conclusion and the Carlat headline that "Industry-Funded CME Must End," I found Barbara's comments very thoughtful. Even so, her analysis does not acknowledge how the CME industry de-evolved over the last 10-years from medical education for doctors to a complete and utter marketing free - for - all. This has had the most deleterious result imaginable, because the "CME business" has become part and parcel of a perception that there exists widespread collusion between industry and science. “Medicine’s for sale!” And it just keeps getting worse at every turn.

On any medical blog, on any given day, you may hear one or more of the following: “Speakers are in bed with industry. Medical education companies (MEC) jury-rig data to suit their client’s drugs as a matter of course. Thoughtleaders are getting rich on industry money while the practitioner treads water. Academic papers are prepared by ghost writers with little or no guidance or editing. Faculty is recruiting grant money on a beach in St. Bart’s -- all expenses paid. A depressed patient suffers because an ‘expert’ advised her doctor to prescribe an antipsychotic and she developed severe Type II Diabetes.”

The Macy Foundation recommendations can begin to temper the groundswell of opinion that implies that medicine is for sale.

The events of the last ten years are as fascinating as they are frightening. In 1997, the FDA endorsed the ACCME's regulations as de facto insurance that "industry-sponsored educational activities are independent and nonpromotional," (See the FDA's Guidance for Industry-Supported Scientific and Educational Activities, Federal Register, Vol. 62, No. 232, 1997). With the stroke of a pen, the agency had unknowingly created a multi-billion dollar CME machine to service the pharmaceutical industry. Ironically, the pharma manufacturers were the biggest victims at first, since a money-gobbling infrastructure sprung up overnight to accredit programming (for a fee of course), which medical schools and teaching hospitals had been doing all along without any problems.

Since pharma was "compelled" following the FDA ruling to acquire CME accreditation for activities to pass regulatory muster, medical education companies (MEC) that specialized in customized CME programming for industry -- and that would work much faster and more closely with the sponsors -- multiplied exponentially.

Few acknowledged at that time that a profound and permanent shift from independent to sponsor CME had begun (including me I might add), because (non-teaching) doctors, who had been paying for Category 1 CME credits out of their own pockets, began receiving them for free -- underwritten, of course, by industry via MEC companies. These companies are enormously proficient at CME programming -- even making the speaker's presentation slides for them. And, thus, we arrive at the most troubling thing about CME: the appearance of collusion.

Barbara’s most compelling argument for the status quo is to say that there is no scientific proof that CME needs changing, hence: “But just as there are limited concrete data regarding the positive effect of CME programs on patient outcomes, there is little information (to my knowledge) regarding the negative effect of pharma-supported CME on practice or patient outcomes. In fact, it is just as probable as not that those health care professionals who attend pharma - supported CME programs have superior medical knowledge and provide superior health care, when compared with their colleagues, owing to the likelihood that the former group is more apt to seek out medical education in all its various forms.”

Does Barbara's argument invalidate the Macy Foundation Chairman's criticism? I don't know. But it leaves more questions than answers in its wake. And I don't think that CME or the doctors it serves deserve any more unanswered questions. We have to admit honestly that CME--and all the bag and baggage that comes with it is broken. Ultimately, even perceptions harden into fact. And that, I submit, is in no one’s best interest.

I'm sorry, but I really have to disagree with all of this. I work for a medical education company, and I can say without any reservation that our CME programs are completely unbiased.

When we get funding from the pharma companies, we have absolutely no contact with them whatsoever about the final content of the activity (they only initially approve the proposal, which contains no information that would be favorably biased toward the pharma company).

The doctors we recruit to conduct the CME activities have no contact whatsoever with the pharma company either, and do not tailor their presentations to benefit the pharma. I would say 99% of the KOLs we recruit are unyieldingly honest and good-natured and got into medicine to help people- not to get rich or push anyone's agenda.

I of course cannot speak for other Med Ed companies, but the one I work for is doggedly honest and unbiased. We create programs that will be useful in educating a broad range of healthcare providers, and would never ever sell out to a pharma to help push their drugs. I think the transparency in CME that has been gained recently has helped to quell people's fears, but I think it's unfair to say that pharma companies should not be able to fund CME. Who else is going to pay for such huge programs? Some of these programs cost upwards of a million dollars... I don't know what government organization is going to shell out that kind of cash for the thousands of programs that occur every year. And if the government gets more involved in regulating it, I think that will severely stifle the creativity that goes into making unique and pragmatic programs. One should think long and hard before making such a harsh statement as to say that pharma companies should no longer CME. Maybe I'm being naive, but I think that would have a huge ripple effect on how care is ultimately provided to patients. It's hard enough to keep doctors up to date on medical advances as-is, but if you severely restrict the funding to educate them, I would lose all faith in a doctor's ability to know the most current treatment options years after they finish med school and residency.

An important clarification: What both the Macy Foundation and other experts are saying is the following: ONE COMPANY CANNOT WORK FOR THE SPONSOR, VET THE PROGRAM, AND ACCREDIT THE CME WITHOUT A REAL AND PRESENT PERCEPTION OF MEDICAL BIAS. It's really that simple.

I am NOT suggesting that the pharmaceutical industry should be barred from supporting CME. That would not be in the best interests of education. Industry -- by-and-large -- develop the pharmaceuticals and have the money to put on the big meetings -- like you say. They sponsor independent monographs, book publishing, and other educational forums that medicine would NOT benefit from losing. (Although I have little doubt that in the scapegoat-crazed environment of today, many would disagree with me.)

What we suggest is that the medical universities -- the very same institutions that educate physicians -- regulate the CME -- not outside third parties. When Med Ed companies became "self regulated" to grant CME to their own clients, that is when the conflict of interest began to grow out of control.

I take you at face value that "We [your company] create programs that will be useful in educating a broad range of healthcare providers, and would never ever sell out to a pharma to help push their drugs." But, perhaps you're being a little naive. Please don't forget that the Med Ed company FIRST goes to "sell" the sponsor on an idea, then develops it WITH the client's full knowledge. When its time to bring the speakers on, the Med Ed company might be running it solo by then, but many months of "market planning" occur well in advance of the program itself. I am sorry to challenge your profession (and I know of many Med Ed companies that are very expert at what they do), but this is just a fact of life. You can't do your job without a paying client and the client wants to know (is mandated to know by its own medical/legal department) what, exactly, it is paying for. So there's your catch 22.

That is why the best way to offer unbiased CME is through medical literature that is peer reviewed and published independently, and -- only then -- can the material be used as the basis of a CME program that can be considered "enduring." That step cannot be bypassed. You can't have the underpinnings of medical or legal precedent until the "decision" is published. Then, and only then, does the true debate begin. Again -- one cannot work for the sponsor, vet the program, and accredit the CME, without a real and present perception of medical bias.

If you or I could be the judge, defense lawyer, and prosecutor -- all at the same time -- it would not be too difficult to "lead the jury" down a path of our own choosing. Would it surprise you to know that the public would not place its faith in such a system?

What I find so surprising by those of you who find pharma company support of medical education so "appalling" is the fact that you are negating your own intelligence in the process. Are you not smart enough to figure out what talks are supported by industry and what talks aren't? Are you so much "above" your peers that you never participate in any activity for monetary gain? Did you get into medicine solely to help humanity or did the idea of making an above average salary never come into the picture? Poppycock. Is it news to you that money has and always be the driver of EVERYTHING in the world? God made man with free will. If we are too stupid to put money and possessions first in our lives then we'll see what's in store for each of us on the back end.

Being "smart enough to figure out what talks are supported by industry and what talks aren't," is not the point.

What we find so "appalling" is NOT pharma company support of medical education -- which, as I have stated -- was not pharma's creation, but the "brainchild" of unwitting FDA regulators. Industry -- in my opinion -- is not the villain. (Though they are sometimes their own worst enemies...but that is another topic of discussion.) The villain is the perception that the "CME business" has become part and parcel of a perception that there exists widespread collusion between industry and science. You might not think this represents an erosion in both professional and public trust, but I do -- and it's in no one's best interest, including the pharma industry, to see this "perception" harden into fact.

Mr. La Rossa, I understand, as do most of us in the CME industry, the concern regarding the potential for, or appearance of, bias in industry-funded CME. I am not arguing with the issue; just struggling to solve it.

1) What data exists to prove bias actually exists? I suspect that the concern arises soley from a philosophy. In the Certified CME profession, we don't include material in our programs that is not evidence based, yet the industry is being attacked w/o solid evidence; how ironic. CME professionals are working diligently in an attempt to document that Certified CME improves patient care. A challenging task indeed, but one that we need to do, and is a focus of our efforts.

2) What will happen to patient care and the health of our nation if industry support of CME is discontinued? What are HCPs willing to pay? Will they seek less expensive alternatives? What will happen to the quality of education? How will HCPs outside the reach of AMCs receive the quality education they sponsor? Do AMCs have the infrastructure to support the services MECs are currently providing? At the end of the day, is it not the same thought leaders that are presenting the content?

Mr. La Rossa, I am infinitely concerned about the ongoing dialogue regarding indusry-supported CME. Industry may very well walk away from supporting CME before any action to prohibit or resolve the funding dilemma is reached. What then?

Don: Thank you for your serious response. Though my answers will prove insufficient, your last question prompted one of my own, which I have been mulling over all day: What happens when the group that has all the money and is providing all the services and is being chronically regulated gets fed up with being overregulated?

I became involved in this debate last year after Danny Carlat asked me to attempt to shed some light on why a journal I had started in the 90’s and sold in ‘03 had recently become embroiled in a seamy CME-for-hire scandal. So, while so much of this looks like it is directed at you and other CME professionals, there are a host of other contributing players, such as medical journals -- all of which spurred the Professional Ethics Report of the AAAS to predict in 2006 that, “We are heading, like the Titanic, towards an iceberg of enormous size.”(1) The report went on to say that, “If industry gets involved in science, it has to balance genuine hypothesis testing and transparency against commercial interests, bureaucracy of drug regulation, and the financial consequences of dishonesty. This is not in itself a criticism – it is a simple fact.”

Unfortunately, and perhaps even unfairly, MedEd Companies (MECCs) are the common denominator in the industry-funded CME debate. MECC’s are the one and only “entity” to interface with the sponsors, the funding, the science, the expert attribution, AND the CME. That’s why you are at ground zero -- it’s a simple fact. Nothing personal. (As far as I’m concerned, I hope you can change your business model and soon, thereafter, retire to Aspen.)

Ironically, some of us caught glimpse of the CME-conflict problem about six years ago when the American Psychiatric Association (APA) began to get very aggressive about retaining exclusive rights to any and all symposia at its meetings. What we saw is that the APA severely tightened up their rules regarding content delivered at the meetings, going so far as to make all speakers sign agreements stating that the APA has exclusive rights to their talks, slides, etc. What they were doing was trying to prevent sponsors and/or outside CME companies from profiting off of these symposia. So the MECCs (being very entrepreneurial) struck back and a CME free-for-all ensued.

You ask three questions. The first is “what data exists to prove bias actually exists?” As I surmise you know, a recent report in a national medical journal surveyed 3,167 physicians in six specialties in an effort to determine bias as a result of physician-industry relationships.(2) Most interesting are some of the references, many of which address your question better than I can.

Your second question is, “what will happen to patient care and the health of our nation if industry support of CME is discontinued?” I am not sure. Probably nothing. To think that physicians will get stupid without pharmaceutical-sponsored CME is, well ...

Your third question was, in effect, what will happen if industry walks away from supporting CME before any action to prohibit or resolve the funding dilemma is reached? This scenario, I believe, is a real possibility. In other words, what happens when the group that has all the money and is providing all the services and is being chronically regulated gets fed up with being overregulated? That, I guess, is when we see what free market economy is all about.

In a “de-regulated” system, I would merge Category 1 and Category 2 CME. Period! There's no need for both. If society cannot trust physicians to abide by the honor system, than we have bigger problems than medical education can cure. When you (the doctor) read a journal or attend a symposia, put the pretest, posttest and answer key in a file in your office. If you're audited you have the proof that you have been continuing your education. The medical community is a much better over-seer than the ACCME. As an MD, if you don't keep up with new science, patients -- some of whom walk and talk like doctors as it is -- will flush that out and make your life miserable. God forbid if you are litigated against. The amount of continuing education, or lack thereof, can come into play in court. So, it is in your personal, professional, and, perhaps, legal interest to stay current with the literature. Ultimately, enforcement becomes moot. Finally, Don changes his business model and retires to Aspen. (Please call me if you’d like to talk -- 800.839.4849.)

James M. la Rossa Jr.MedWorks Media GlobalLos Angeles, CA

(1) Professional Ethics Report. AUTHORSHIP, GHOST-SCIENCE, ACCESS TO DATA AND CONTROL OF THE PHARMACEUTICAL SCIENTIFIC LITERATURE: WHO STANDS BEHIND THE WORD?Number 3, Volume XIX (Summer 2006); Publication of the American Association for the Advancement of Science, Scientific Freedom, Responsibility & Law Program in collaboration with the Committee on Scientific Freedom & Responsibility, Professional Society Ethics Group.